OBJECTIVE

To obtain a challenging position utilizing my managerial, analytical skills, Regulatory Affairs experience, Quality experience, and GMP knowledge.

SUMMARY OF QUALIFICATIONS

Technical

ISO 9001:2008

Management of QMS

Data collection and analysis

Tested and validated products

Lead Internal Audits assisted on facility Surveillance Audits

CAPAs

ISO 13485

Supplier Auditing/Approval

Agile (Oracle based systems)

SAP

Device drawing understanding including terminology and tolerances etc.

Microsoft Office

Excel (reports and presentations)

Communication

Established fundamental relationships between Engineering and Quality departments to enhance project work and resolve issues quickly

Developed rapport with contracted clients upper management

Authored Qualification reports to document product safety and Protocol reports

EDUCATION

B.A. Biology, Southwest State University, Marshall, MN 2002

PROFESSIONAL DEVELOPMENT

Leica Biosystems (contract through Kelly Services) Jan 2017-Current

Regulatory Affairs Specialist

Technical File updating and organization

Cardinal Health (contract through Hiregenics) Oct 2016-Jan 2017

Regulatory Affairs Data Coordinator

GE Healthcare (contract through Tech Mahindra)

UDI Regulatory Affairs Specialist Mar 2014-Jul 2016

Create Registration programs for US and EU countries registered products in IRIS

Create US and EU country records for each Registration in the International Regulatory Information Systems (IRIS an Agile based System)

Complete UDI attributes for each country record

Attach Product Model information for US for each, individual program

Troubleshooting areas of error within system by accurately conveying issue to IT for expedited system errors

Training through an internal database to stay in compliance with the FDA and ISO standards

Merz North America (contract through Pinpoint Pharma)

Regulatory Affairs Specialist Jul 2013-Dec 2013

Drug Manufacturer’s State Licensing renewals for Warehouse and Drug Distributors

Drug Manufacture’s State Licensing name changes for Warehouse and Drug Distributors

Documentation organization

Communication with varying states to get licensing within regulation

Updating of Registration Documents (Declaration of Conformity) for the EU Countries

PROFESSIONAL DEVELOPMENT CONTINUED

Hospira (contract through Experis) Mar 2013-Jul 2013

Document Coordinator

Document Searches and Management

ANDA doc package creation for the Regulatory Affairs Department

Package creation of the quality, regulatory, microbiology, and chemistry departments gap assessments were done

Led and assisted field staff in the Gap Analysis project

Utilized various Company databases to obtain required information

Provided feedback and project updates to Project Manager

Hospira (contract through Kelly Services)

IT Data Entry Supervisor/ ECCM Team Member May 2012-Mar 2013

Data Entry Supervisor of other contracted data entry personnel

Document management

Data entry and data entry management

Cransoft/BackOffice maintenance

Change Management

ECCM migration into SAP

Document (Device Drawing) searches and organization

Consulted with the Device Drawing SME’s to get their knowledge and feedback regarding drawings

Timely updates to project manager on project progress

Hospira (contract through Kelly Scientific)

Regulatory Affairs Associate Jan 2012-May 2012

Data mining/entry

Document Management

Weekly conference calls with Regulatory Personnel with Latin America and Asia Pacific regions

FURLS (FDA Unified Registration and Listing System)

Redlining of documents

SAP System

Document Management

Training through an internal database to stay in compliance with the FDA and ISO standards

RMS Quality Services

Quality Assurance Manager/Consultant Mar 2011-June 2011

Managed RMS’ Quality System (ISO/IEC 17025 Accredited)

Consultant for ISO Quality Systems of contracted clients in various disciplines and maintenance of their quality systems, including management reviews

Internal Audits and External Audit support

CAPAs

Redlining of SOP’s

Maintained calibration maintenance log and sent out equipment needing to be calibrated

Meet and consult with plant managers, company CEO’s as well as other departments regarding ISO regulations

Developing a rapport with top level management

Traveling to client locations via auto

PROFESSIONAL DEVELOPMENT CONTINUED

Baxter (contract through Kelly Scientific)

Corporate Quality FCA Data Analyst Apr 2010-Dec. 2010

Field Corrective Action analyzing data and trending for Baxter Global

Managed the data for the renal, biologics, and medical device divisions

Construction and submittal of reports used for data tracking within the FCA Dept

Consultation with various managers to obtain accurate information for reports

KPIs (Key Point Indicators) updating the graph board of out depts.. KPIs

Training through an internal database to stay in compliance with the FDA and ISO standards

Provided pharmacovigilance calls to users of In Home Dialysis Unit for the Renal Division

Consultation/communication with Managers in offsite areas to track their dat

Hospira (contract through Kelly Scientific)

Device Product Development Lab Technician Jan 2008-Jan 2010

Tested and evaluated medical products (including sterile medical devices) using JIS, FDA, and ISO standards

Consulted with Engineers on test results obtained during testing

Analyzed test results

Training through an internal database to stay in compliance with the FDA and ISO standards

SC Johnson (contract through Adecco)

R,D&E Technician Jan 2006- Jul 2007

Tested and evaluated home care products for effectiveness and safety

Analyzed and compiled data and generated qualification reports

Managed functional aspects of the lab including procurement of supplies, cleaning, stock organization, purging of test samples

Discussed results with formulation chemists

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